Approval and regulation

Before being marketed, all phytopharmaceutical products must be assessed by the relevant authorities in the countries concerned. In Europe, directive 91/414/CE sets out the conditions that an active substance or phytopharmaceutical product must satisfy in order to be approved.

Agriphar’s “approval” department is responsible for collating studies into a dossier for assessment by the relevant authorities. The sections of the dossier that concern the physical and chemical properties of the product and analysis methods are mainly the responsibility of the laboratory. A significant portion of the dossier is also dedicated to the human health risk assessment